NCT02919982

Brief Summary

The purpose of this study is to establish a benchmark for rate of prescription of oral anticoagulants (OA) in patients with non-valvular atrial fibrillation (NVAF) seen in an ambulatory care setting, based on independent medical assessment of clinical data and physician and patient surveys. The study will also assess reasons for not prescribing OA to prevent thromboembolic complications in patients with NVAF seen in ambulatory care, and patients' perspectives of non-use of OA for treatment of NVAF.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
817

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

1.3 years

First QC Date

September 26, 2016

Last Update Submit

July 25, 2022

Conditions

Nonvalvular Atrial Fibrillation

Keywords

AnticoagulantNonvalvular atrial fibrillationRegistries

Outcome Measures

Primary Outcomes (1)

  • A benchmark rate of OA treatment in patients with NVAF

    This rate of OA will be based on assessment of appropriateness of OA treatment based on clinical guidelines by cardiologists using clinical data and the physician and patient surveys.

    Baseline

Secondary Outcomes (1)

  • Physician Reason for not prescribing OA; Patient perspectives on non-use of OA

    Baseline

Other Outcomes (1)

  • Change in rate of OA use

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes, from participating centers within the PINNACLE Registry, patients with nonvalvular atrial fibrillation identified as having an indication for oral anticoagulants, according to guidelines developed by the American College of Cardiology, but not receiving them.

You may qualify if:

  • Able and willing to complete the survey;
  • Diagnosed with nonvalvular atrial fibrillation and CHA2DS2-VASc ≥ 2;
  • Not currently treated with oral anticoagulants according to the PINNACLE Registry data;
  • Enrolled in the PINNACLE Registry;
  • Last physician office visit within the prior 18 months; and
  • Age ≥ 18 years.

You may not qualify if:

  • Patient is no longer being followed at the local practice;
  • Patient declines participation; and/or
  • Patient is unable to speak or read English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Alaska Heart Institute

Anchorage, Alaska, 95508, United States

Location

Orange County Heart Institute and Research Center

Orange, California, 92868, United States

Location

Clearwater Cardiovascular & Interventional Consultants MD PA

Clearwater, Florida, 33756, United States

Location

Holy Cross Hospital, Inc.

Fort Lauderdale, Florida, 33308, United States

Location

Heartwell LLP

Miami, Florida, 33173, United States

Location

Cardiac Institute of the Palm Beaches

Palm Beach Gardens, Florida, 33410, United States

Location

Adventist Health Partners, Inc. Amita Health

Hinsdale, Illinois, 60521, United States

Location

Delmarva Heart LLC

Salisbury, Maryland, 21804, United States

Location

Michigan Heart - St. Joseph Mercy Health System

Ann Arbor, Michigan, 48197, United States

Location

Munson Medical Group

Traverse City, Michigan, 49684, United States

Location

CardioCare, PC

Hillsborough, New Jersey, 08844, United States

Location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Southern Oregon Cardiology

Medford, Oregon, 97504, United States

Location

Cardiology Consultants of Philadelphia - Lansdale

Lansdale, Pennsylvania, 19446, United States

Location

The Heart Institute of East Texas

Lufkin, Texas, 75904, United States

Location

Waco Cardiology Associates

Waco, Texas, 20037, United States

Location

Revere Health-Heart of Dixie Cardiology Central Utah Clinic PC

St. George, Utah, 84790, United States

Location

Centra Health, Inc. dba Stroobants Cardiovascular Center

Lynchburg, Virginia, 24501, United States

Location

Virginia Cardiovascular Specialists

Richmond, Virginia, 23229, United States

Location

Western Washington Medical Group, Inc.

Everett, Washington, 98208, United States

Location

Kootenai Health dba Heart Clinics of the Northwest

Spokane, Washington, 99204, United States

Location

Study Officials

  • Christopher P Cannon, MD

    Baim Institute for Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 30, 2016

Study Start

January 1, 2017

Primary Completion

May 1, 2018

Study Completion

September 1, 2019

Last Updated

July 27, 2022

Record last verified: 2022-07

Locations

US(21)